| |
Analytical Chemistry Services
Employing state-of-the-art instrumentation in HPLC, GC, GC/MS and LC/MS/MS, Synomics Pharma can develop analytical chemistry methods from first principles to validation and can verify or improve existing methods for the analysis of a wide range of active compounds. Customized analytical chemistry testing and structure elucidation are also offered. All services can be provided to meet either GLP or cGMP guidelines (or non-GLP as requested):
Analytical Chemistry Services
- Method development
- Method validation
- Method verification/transfer
- Sample analysis
- Lot and batch release testing
- Structure elucidation
- Detection and identification of impurities
- Residual solvent analysis
- Dissolution testing
- Product composition
- Content – uniformity/impurities
- Customized LC/MS/MS method development
- Raw material testing
- Placebo and excipient testing
- Physical-chemical properties
- Customized analytical testing
Expertise
Proteins and Peptides
- Client specific compounds(Oncology, Neurological, and Antibody conjugates)
Glycosylated Peptides/proteins (HPLC Corona Aerosol Detector & LC/MS/MS) and
Small Molecules
- Oncology
- Hormones/prostaglandins
- Cyclodextrins
- Vitamin D derivatives
- Anti-inflammatory
Stages of Development
- Discovery (Non-GLP)
- Pre-clinical (GLP)
- Clinical (GLP/GMP)
- Commercial (cGMP)
|